September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.

January 4, 2010 -
This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

March 3, 2009 - See Notice (NOT-HG-09-009) The purpose of this notice is to change the March 2, 2009 receipt date.

November 10, 2008 - See Notice (NOT-HG-09-005) he purpose of this Notice is to correct the list of required components of the application.

Program
Announcement (PA) Number: PAR-08-258

NOTICE: Applications submitted in response
to this Funding Opportunity Announcement (FOA) for Federal assistance must be
submitted electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT
BE SUBMITTED IN PAPER FORMAT.

This FOA must be read
in conjunction with the application guidelines included with this announcement
in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process
is necessary before submission and applicants are highly encouraged to start
the process at least four (4)weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.172

Key
Dates (Updated per NOT-HG-09-015)Release/Posted Date: August 28, 2008Opening Date: October 3, 2008 (Earliest date an application may be submitted to Grants.gov) NOTE: Application Due Date(s): November 3, 2008, March 2, 2009, New Dates (per NOT-HG-09-009): July 12, 2009, September 22, 2009, November 12, 2009, January 20, 2010; March 12, 2010; May 20, 2010; July 12, 2010, September 22, 2010; November 12, 2010, January 20, 2011; March 11, 2011, May 20, 2011; July 12, 2011.Peer Review Date(s): December-January 2009, April-May 2009, August-September 2009, New Dates (per NOT-HG-09-009): November 2009; January 2010, March 2010; April-May 2010, July 2010, September 2010, November 2010, January 2011, March 2011, April-May 2011, July 2011, August-September 2011. Council Review Date(s): January 2009, May 2009, October 2009, January 2010, May 2010, October 2010, January 2011, May 2011, October 2011, Earliest Anticipated Start Date(s): March 1, 2009 , July 1, 2009, December 1, 2009, New Dates (per NOT-HG-09-009): January 1, 2010, February 26, 2010, April 23, 2010, June 25, 2010; August 27, 2010, November 1, 2010;January 1, 2011; February 25, 2011; April 29, 2011, June 24, 2011; August 26, 2011, and December 1,2011. Information To Be Available Date (Activation Date): Not Applicable Expiration Date: July 2, 2011

Key
Dates (Original)Release/Posted
Date: August 28,
2008Opening Date: October 3, 2008 (Earliest date an application may be
submitted to Grants.gov)NOTE: On-time
submission requires that applications be successfully submitted to Grants.gov
no later than 5:00 p.m. local time (of the applicant institution/organization. Application Due Date(s): November 3, 2008, March 2, 2009, New Date: March 9, 2009 (per NOT-HG-09-009) July 1, 2009, November 2,
2009, March 2, 2010, July 1, 2010, November 1, 2010, March 1, 2011, July 1,
2011Peer Review Date(s): December-January 2009, April-May
2009, August-September 2009, December-January 2010, April-May 2010,
August-September 2010, December-January 2011, April-May 2011, August-September
2011. Council Review Date(s): January 2009, May 2009, October
2009, January 2010, May 2010, October 2010, January 2011, May 2011, October
2011, Earliest Anticipated Start
Date(s): March 1, 2009 ;July 1, 2009; December 1, 2009; March 1, 2010; July 1,
2010; December 1, 2010; March 1, 2011; July 1, 2011; and December 1;2011.Information To Be Available Date
(Activation Date):Not ApplicableExpiration Date: July 2, 2011

Due Dates for E.O. 12372

Not Applicable

Additional
Overview Content

Executive Summary

Purpose: CIDR high-throughput genotyping
and supporting statistical genetics services are designed to aid investigations
seeking to identify genes that contribute to human health and disease. The
services provided through CIDR concentrate primarily on multi-factorial
hereditary disease, but other types of projects can also be accommodated.
CIDR provides the most up-to-date genotyping platforms and services. This
is an NIH-wide initiative that is being managed by NHGRI. Information
about the current services offered can be accessed via:
http://www.cidr.jhmi.edu.

Mechanism
of Support.This FOA will utilize
the X01 grant mechanism. There are no funds
associated with a resource access award. However, the NIH does support the
genotyping done through its funding of CIDR. Applicants must get prior
approval from an NIH supporting institute (http://www.cidr.jhmi.edu) or
otherwise explain how the genotyping will be supported.

The
applications will be coded X01s. There are no dollars associated with these
requests and receipt of access does not result in funds being awarded to the
applicant.

The
total number of projects granted CIDR access is
dependent on the number of meritorious applications and the availability of
resources at CIDR.

Eligible Project Directors/Principal Investigators (PDs/PIs).Individuals with the skills,
knowledge, and resources necessary to carry out the proposed research are
invited to work with their institution/organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIH
support.

Number
of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the
application.

Number
of Applications. Applicants may submit more than one application,
provided that each application is scientifically distinct.

Resubmissions.Applicants
may resubmit for projects that are denied access, but they must include a one
page introduction addressing the previous peer review.

Renewals. Applicants may submit a
renewal application.Continuation
projects must be submitted as a new application with explanation.

Application
Materials.SeeSection IV.1for application materials.All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.

General Information.For general
information on SF424 (R&R) Application and Electronic Submission, see these
Web sites:

With the
recent advances in our ability to detect human genetic variation, there is
tremendous interest in applying the new technology to find genetic elements
important in human health and disease.
However, because most high throughput genotyping technologies can not be
efficiently carried out in individual investigator laboratories, there is great
need for access to facilities that provide state-of-the-art
genotyping services. CIDR fulfills this need for many kinds of projects
including whole genome association studies (GWAS); genome-wide linkage
analyses, and follow-up replication and fine mapping studies.

Objectives:

This FOA is to provide access to full-service
high-throughput genotyping to aid the discovery of genetic elements important
in health and disease. Investigators interested in taking advantage of this
resource should submit an application for access to CIDR genotyping. The
application should include: justification for the service requested; detailed
information about the sample DNA and its source; a clear description of the
study design and its rationale; plans for data management and analysis and a
description of follow-up plans.

This FOA is
seeking projects that show promise of identifying genetic element(s) that are
important to human health and disease. There should be strong evidence that
the study design and analysis proposed are likely to have the power to detect
genetic factors affecting the trait under study. In addition, there should be
a clear need for the particular high-throughput service requested. Types of
projects would include but not be limited to: Human GWAS studies for common
human diseases; genome-wide linkage analyses, and follow-up replication and
fine mapping of GWAS projects.

This
FOA will use the X01 award mechanism to provide access to the CIDR
high-throughput genotyping resource. Investigators are expected to provide properly
prepared and aliquoted DNA and supporting documentation for all samples to be
typed.

2. Funds
Available

Applications in response to
this FOA will not receive any additional funds or personnel to use the
resource. Applicants must document authorization from a participating NIH
institute (http://www.cidr.jhmi.edu) to apply or provide other documentation of
how the genotyping costs would be supported if access is granted.

The decision of whether to
apply for a grant with a single PD/PI or multiple PDs/PIs grant is the
responsibility of the investigators and applicant organizations and should be
determined by the scientific goals of the project. Applications for grants with
multiple PDs/PIs will require additional information, as outlined in the
instructions below. When considering the multiple PD/PI option,
please be aware that the structure and governance of the PD/PI leadership team
as well as the knowledge, skills and experience of the individual PDs/PIs will
be factored into the assessment of the overall scientific merit of the
application. Multiple PDs/PIs on a project share the authority and
responsibility for leading and directing the project, intellectually and
logistically.Each PD/PI is responsible and accountable to the grantee
organization, or, as appropriate, to a collaborating organization, for the
proper conduct of the project or program, including the submission of required
reports. For further information on multiple PDs/PIs, please seehttps://grants.nih.gov/grants/multi_pi.

Applicants may resubmit for projects that have been denied access, but
they must include a one page introduction addressing the previous peer review.

If the
project is a continuation of a previous CIDR project, it must be submitted as a
new application. However, please be sure to clearly
explain in the abstract and specific aims sections the relationship of this
submission to the parental CIDR project.

Applicants
may submit more than one application, provided that each application is
scientifically distinct.

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for
Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual(s) designated as
PDs/PIs on the application must be registered also in the NIH eRA Commons.In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned
the PI role in the eRA Commons prior to the submission of the application.

Each PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist
under one Commons account.

When multiple PDs/PIs are
proposed, all PDs/PIs at the applicant organization must be affiliated with
that organization.PDs/PIs located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.

This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD(s)/PI(s)
and AOR/SO need separate accounts in the NIH eRA Commons since both are
authorized to view the application image.

Note that if a PD/PI is
also an NIH peer-reviewer with an Individual DUNS and CCR registration, that
particular DUNS number and CCR registration are for the individual reviewer
only. These are different than any DUNS number and CCR registration used by an
applicant organization. Individual DUNS and CCR registration should be used
only for the purposes of personal reimbursement and should not be used on any
grant applications submitted to the Federal Government.

Several of the steps of
the registration process could take four weeks or more. Therefore, applicants
should immediately check with their business official to determine whether
their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.

Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are required by NIH (e.g., the Credential log-in
field of the Research & Related Senior/Key Person Profile component must
contain the PD/PIs assigned eRA Commons User ID). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see Frequently Asked Questions Application
Guide, Electronic
Submission of Grant Applications.

The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

Proposed research should provide special opportunities for
furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions in other countries that are not
readily available in the United States (U.S.) or
that augment existing U.S. resources.

SPECIAL
INSTRUCTIONS

Applications with
Multiple PDs/PIs

When multiple PDs/PIs
are proposed, NIH requires one PD/PI to be designated as the "Contact PI,
who will be responsible for all communication between the PDs/PIs and the NIH,
for assembling the application materials outlined below, and for coordinating
progress reports for the project. The contact PD/PI must meet all eligibility
requirements for PD/PI status in the same way as other PDs/PIs, but has no
other special roles or responsibilities within the project team beyond those
mentioned above.

Information for the
Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover
component.All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of
PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included
in the Credential field of the Research & Related Senior/Key Person
component.Failure to include this data field will cause the application
to be rejected.

All projects proposing Multiple PDs/PIs will
be required to include a new section describing the leadership plan approach
for the proposed project.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new
section of the research plan, entitled Multiple PD/PI Leadership Plan, must be
included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership team
and the research project should be described, and should include communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts.The roles and administrative, technical, and
scientific responsibilities for the project or program should be delineated for
the PDs/PIs and other collaborators.

If budget allocation
is planned, the distribution of resources to specific components of the project
or the individual PDs/PIs should be delineated in the Leadership Plan. In the
event of an award, the requested allocations may be reflected in a footnote on
the Notice of Award (NoA).

Applications
Involving a Single Institution

When all PDs/PIs are
within a single institution, follow the instructions contained in the SF424
(R&R) Application Guide.

Applications
Involving Multiple Institutions:

Not Applicable

The research plan must include the following information:

Introduction: If the project is a resubmission, a 1-page introduction (not
counted in the page limit) must be included.

Specific Aims: This section should include an outline of the
project design and how the service(s) being requested will facilitate those
aims.

Background: Provide the relevant background to justify the
request. Be sure to Include:

1. The
public health significance of the trait, the evidence for a genetic component
and the likely strength of that component. Include data from appropriate
studies such as twin studies, family clustering/segregation studies, etc. In
addition, describe the anticipated genetic complexity of the trait (e.g.
whether a single, a few or many genes are likely to be involved, anticipated
gene-gene interactions) as well as any relevant published molecular genetic
studies on the trait of interest.

2. Information
on any genes known to be involved in the trait.

3. Information
on any known (non-genetic) risk factors associated with the trait.

4. For
requests of custom SNP typing to follow up a linkage or association study,
describe the previous study in detail (its design, samples, phenotypes and
results). Also specify whether or not the samples to be used for the follow-up
study are independent of those in the original study.

5. Any
other background directly relevant to the study proposed.

Approach (A-D below):

A. Sample Information:

1. Include
detailed information about what samples are requested to be typed and what
service(s) are requested. When more than one service is requested, clearly
describe which service will be used with which samples. If you will be
combining the results from the proposed study with those obtained from samples
that have already been genotyped, be sure to explain how the requested typing
will fit in with your overall study design. Applications requesting
high-density SNP genotyping for GWAS studies at CIDR must have subject
recruitment and phenotypic characterizations completed prior to submission.

2. Include
a clear description of the source of all DNA samplesand extraction method(s)
used. See http//www.cidr.jhmi.edu for details on DNA source, concentration,
volume and source requirements for the service requested.

3. State
whether any of the samples have been previously genotyped. If so, briefly
describe the nature of the study, and in particular report results pertinent to
DNA quality (e.g., success rate of genotyping per locus.)

4. State
approximately when samples would be available to ship to CIDR.

B. Project Details:

1. Description
of the disease/trait: Describe the disease/trait(s) under study and give
detailed information about the phenotypic characterization of the subjects.
Describe any relevant endophenotypes or secondary phenotypes that have been
measured. Describe environmental factors that have been measured that might
influence genotype-phenotype associations or might otherwise deserve
consideration in the analysis.

2. Study
Population: Describe the study population and the method of selection. If a
case-control study, provide specific inclusion and exclusion criteria for cases
and controls; if applicable, describe how cases were identified and sampled,
how controls were matched to cases and how effective the matching has been.
For trios and families define how offspring were identified and the
completeness of pedigrees, including whether parentage was confirmed by
genotyping. Describe any special features of the population that would enhance
its value for the study proposed. For mouse studies, provide reasons for
strain choices.

3. Study
Design: Provide a detailed description and justification of the study design.
If a multistage genotyping design is proposed, discuss plans for each stage.
Provide details about the choice of platforms and, for a custom SNP project,
how SNPs would be or have been selected. Explain any power and/or cost
advantages of the design proposed over other plausible study designs.

4. Justification:
Provide a clear justification for the particular service requested. For GWAS,
this should include a justification for the array chosen; for custom SNP
projects, this should include a justification for the choice of service and
number of SNPs requested.

5. Power
and effect size: Describe the power of the project and the anticipated size of
a detectable genetic effect (e.g. main effect of a single gene, or gene-gene
interaction effect size). If appropriate under your study design, include a
separate analysis of subjects in various phenoytpic classes and the power of
each class to reach a significant finding.

6. Data
Analysis: Provide a thorough and detailed plan for data analysis. Examples of
the expected elements of this section include the analytical approaches to be
used and their justification; plans to account for genotyping errors and, if
relevant, phenotypic uncertainty in the analysis; how false positive rate will
be controlled; whether gene-gene and/or gene-environment interactions will be
evaluated; and, if relevant, how the trait or locus will be localized. Include
a brief summary of the teams expertise and experience and evidence that they
can handle the analysis proposed.

7. Data
Management: Describe how the data are to be managed such as type of data base,
who will maintain and update it, and who will have access to it. Highlight
experience with data management for large data sets, such as those to be
produced by the proposed project.

8. Plans
for the next phase: Describe plans for follow up studies: e.g., additional
genotyping and/or DNA sequencing, replication studies, functional testing of
variants. If collaborations have been established for follow up, include these
letters of collaboration.

C. Project Support: Describe whether there is
current NIH funding to support the research project and if so, provide the
grant number(s) and what study section(s) were involved in the review.
Indicate whether you have support of one of CIDRs supporting NIH institutes
(see http//www.cidr.jhmi.edu for a list of supporting institutes). If yes, indicate
which one and provide supporting documentation; if not, explain how genotyping
costs will be paid. A list of participating NIH Institutes and their CIDR
contact person can be found at: http://www.cidr.jhmi.edu.

D. Data Sharing Plan: For GWAS projects, the applicant
should explain their plans for sharing individual genotypic and phenotypic data
with the research community.

Data Dictionary and Data Summary: Applications requesting high
density genome-wide SNP genotyping for a genome wide association must submit: a
data dictionary for all measures to be shared and a summary of the phenotypic
data collected. Attach
these documents as separate attachments using the Other Attachments
attachment on the Research Related Other Project Information page. Name the
attachments Data Dictionary and Data Summary.

Letters of Support: Letters of support from collaborators should be
submitted. If the collaborator is not directly supported by the parent project,
the letter should address what role the collaborator would play in the proposed
project, the fraction of dedicated time that will be devoted to this project
and the source of support for that time. Attach the letters using the letters
of support attachment under the PHS 398 Research Plan.

Research
plan guidelines that are customized for the service requested can be found at: http//www.cidr.jhmi.edu.

Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant
institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s)
and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully
submitted through Grants.gov, any errors have been addressed, and the assembled
application has been created in the eRA Commons, the PD/PI and the Authorized Organization
Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday,
excluding Federal holidays) to view the application image to determine if any
further action is necessary.

If everything is acceptable, no
further action is necessary. The application will automatically
move forward to the Division of Receipt and Referral in the Center for
Scientific Review for processing after two weekdays, excluding Federal holidays.

Prior to the submission deadline, the
AOR/SO can Reject the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to Reject the application and
submit a Changed/Corrected application. In
these cases, please contact the eRA Help Desk to ensure that the issues
are addressed and corrected. Once rejected, applicants should follow the
instructions for correcting errors in Section 2.12, including the
requirement for cover letters on late applications. The
Reject feature should also be used if you determine that warnings are
applicable to your application and need to be addressed now. Remember,
warnings do not stop further application processing. If an application
submission results in warnings (but no errors), it will automatically move
forward after two weekdays if no action is taken. Some warnings may
need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to Reject the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or did not
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course
of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to Reject the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two days.

Upon
receipt, applications will be evaluated for completeness by the Center for
Scientific Review, NIH. Incomplete applications will not be reviewed.

There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their application status in the Commons.

The NIH will not
accept any application in response to this FOA that is essentially the same as
one currently pending initial merit review unless the applicant withdraws the
pending application. The NIH will not accept any application that is
essentially the same as one already reviewed. However, the NIH will accept a
resubmission application, but such application must include an Introduction
addressing the critique from the previous review.

The
NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE
Project Director/Principal Investigator section, Credential log-in field
of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For
additional information, see Frequently Asked Questions Application Guide, Electronic
Submission of Grant Applications.

PHS398 Research Plan Component Sections

Page
limitations of the PHS398 Research Plan component must be followed as outlined
in the SF424 (R&R) Application Guide, with the following requirement for CIDR
X01 applications:

Item 3 of the PHS398 Research Plan component
of the X01 application may not exceed 6 pages.

For all
applications involving NIH institute support of the genotyping costs, institute
pre-approval is required.

Resubmissions
(amended applications) must include a 1 page introduction to address the
concerns of the previous summary statement.

For genome wide
association studies (GWAS) requesting CIDR access, it is required that the
phenotypic measures and DNA have been collected from all subjects before submission of the application to CIDR.

All GWAS applications to CIDR must
include a data dictionary of the phenotypic measures to be shared in dbGaP, a summary table of the phenotypic data collected, and the
protocols and questionnaires used. It is also required
that the application include a letter from the institution certifying the
data sharing that will be allowed and providing assurance that the data to
be submitted were collected in a manner consistent with 45 C.F.R Part
46. These items are not counted in the page limit for the research
strategy. Attach these documents as
separate attachments using the Other Attachments attachment on the
Research Related Other Project Information page. Name the attachments
Data Dictionary and Data Summary.

While
each section of the Research Plan needs to be uploaded separately as
a PDF attachment, applicants are encouraged to construct the Research Plan
component as a single document, separating sections into distinct PDF
attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits. All
attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be
used.

All
application instructions outlined in the SF424 (R&R) Application Guide are
to be followed, incorporating "Just-in-Time" information concepts,
and with the following additional requirements:

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page
limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers
the sharing of unique research resources developed through NIH-sponsored
research an important means to enhance the value and further the advancement of
the research. When resources have been developed with NIH funds and the
associated research findings published or provided to NIH, it is important that
they be made readily available for research purposes to qualified individuals
within the scientific community. If the final
data/resources are not amenable to sharing, this must be explained in the
Resource Sharing section of the application (see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(b) Sharing Model Organisms: Regardless of
the amount requested, all applications where the development of model organisms
is anticipated are expectedto include a description of a
specific plan for sharing and distributing unique model organisms and related
resources or state appropriate reasons why such sharing is restricted or not
possible (see Sharing
Model Organisms Policy, and NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Applicants seeking CIDR genotyping
for a genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate explanation why submission to the repository is
not possible. A genome-wide association study is defined as any study of
genetic variation across the entire genome that is designed to identify genetic
associations with observable traits (e.g., blood pressure or weight) or the
presence or absence of a disease or condition. For further information
see Policy for Sharing of Data Obtained in NIH Supported or Conducted
Genome-Wide Association Studies (go to NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.)

Foreign Applications
(Non-domestic [non-U.S.] Entities)

Indicate
how the proposed project has specific relevance to the mission and objectives
of the NIH/IC and has the potential for significantly advancing the health
sciences in the United States

Section V. Application Review Information

1.
Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only
the review criteria described below will be considered in the review process.

2. Review and
Selection Process

Applications that are complete will be evaluated for scientific
and technical merit by an appropriate peer review group convened by NHGRI and
in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review
criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo a
selection process in which only those applications deemed to have high
scientific and technical justification for the requested genotyping with
be recommended for access and assigned an impact/priority score.

Receive a
written critique; and

They
receive a final decision about access by the CIDR Board of Governors (an
inter-institute NIH committee).

The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, and weighted as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a meritorious impact/priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the trait under
study significant to human health? Is there strong evidence for a genetic
component, and documentation of the anticipated size of the genetic effect?
Does the genetic complexity of the trait support the need for high-throughput
genotyping? Are the proposedstudies likely to provide important new information
about genetic variants important in human health or disease?

Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the genetic
markers requested appropriate for the question addressed? Are the specific
phenotypic measures and environmental measures appropriately chosen and
carefully determined? Is the study design appropriate for the specific trait
mapping project proposed? Does the sample set have the power to detect a
genetic effect? Are there strong plans for data management and data analysis? Are there adequate
plans for follow-up studies to identify specific genes or genetic variant(s)
affecting the risk of the disease or influencing quantitative trait variation?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

2.A.
Additional Review Criteria

In addition to
the above criteria, the following items will be considered in the determination
of scientific merit and the rating:

Resubmission
Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children: When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals: The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.

2. B. Additional Review Considerations

As applicable for the
project proposed, reviewers will address each of the following items, but will
not give scores for these items and should not consider them in providing an
overall impact score.

Budget and Period of
Support:
Not Applicable

Applications
from Foreign Organizations: Reviewers will assess whether the project
presents special opportunities for furthering research programs through the
use of unusual talent, resources, populations, or environmental conditions
that exist in other countries and either are not readily available in the
United States or augment existing U.S. resources.

2.C. Resource Sharing
Plan(s)

When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of
scientific merit or impact/priority score, unless noted otherwise in the FOA. Program
staff within the IC will be responsible for monitoring the resource sharing.

After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons.

After the CIDR Board of
Governors meeting, the applicant will receive a letter outlining the
final decision about access to CIDR.

2. Administrative and National Policy Requirements

Access to CIDR will
depend on meeting the terms outlined in the Board access letter and following the terms and agreements required by the CIDR
laboratory as described at www.cidr.jhmi.edu.

3. Reporting

CIDR and the NIH should
be acknowledged in any publications resulting from this research.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research (program), peer review, and financial or
grants management issues:

Human Subjects
Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (https://grants.nih.gov/grants/policy/data_sharing).Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local institutional review board (IRB) rules, as well as local,
State and Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the impact/priority score.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For
additional information, see https://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women, Minorities, and Children:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require for
all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy,investigators
funded by the NIH must submit or have submitted for them to the National Library of
Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version
of their final, peer-reviewed manuscripts upon acceptance for
publication, to be made publicly available no later than 12 months after the
official date of publication. The NIH Public Access Policy is available
at (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding
must be self-contained within specified page limitations. For publications
listed in the appendix and/or Progress report, Internet addresses (URLs) or
PubMed Central (PMC) submission identification numbers must be used for
publicly accessible on-line journal articles.Publicly accessible on-line
journal articles or PMC articles/manuscripts accepted for publication that are
directly relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This program is described in
the Catalog
of Federal Domestic Assistance athttp://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372. Awards are
made under the authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42
CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and discourage
the use of all tobacco products. In addition, Public Law 103-227, the
Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some
cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan
Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.